Field
The invention generally relates to medical devices and procedures, and more particularly bodily implants and their implantation into a body of a patient to support body tissues.
Description of the Related Art
Urinary Incontinence (UI) is loss of bladder control, which results in involuntary leakage of urine. Incontinence may be caused by many different medical problems in muscles and nerves that help to hold or release urine. The four basic types of UI are stress incontinence, urge incontinence, mixed incontinence, and overflow incontinence. Stress Urinary Incontinence (SUI) is a condition in which a patient leaks urine due to a sudden increase in the abdominal pressure. This increase in abdominal pressure can result from daily activities such as laughing, sneezing, walking, and the like.
Another type of incontinence that involves involuntary passage of feces through an anal canal is fecal incontinence. This type of disorder may be caused due to weakness or damage of internal and external anal sphincter muscles or levator ani muscles surrounding the anal canal in a human body.
A variety of surgical and non-surgical techniques are adopted to treat disorders and damages associated with UI and fecal incontinence. One such surgical treatment includes a sling procedure in which bodily implants such as slings are disposed into a patient's body, e.g., around a bladder neck to treat UI and around the anal canal to treat fecal incontinence.
The sling procedure may be performed using strips of natural materials, such as body tissue, or synthetic material or mesh (e.g., polypropylene mesh). In some embodiments, slings can have high rates of effectiveness and low risks of complications. In the recent years, the synthetic sling materials have gained popularity along with the procedure of placing the sling in the area of the mid-urethra to treat UI.
In some cases, the sling procedure is performed under either a general or spinal anesthetic. The UI sling procedure may be performed using either a pubovaginal technique or a transvaginal technique. In the pubovaginal technique, an incision is made above a pubic bone and another incision is made in a vaginal wall, through which the sling is grasped and adjusted around the bladder neck. The sling is then secured by two sutures that are loosely tied to each other above the pubic bone incision, thus providing a hammock like support to the bladder neck. However, in the transvaginal technique, a small incision is made only in the vaginal wall of the patient. The sling is then inserted into the vagina through this incision to support the bladder, the bladder neck, a urethra, and a urethral sphincter of the patient. Irrespective of the sling technique used, the placement of the sling inside the body of the patient helps to restore the normal urinary function of the patient.
During the sling procedure, the amount of tension may be difficult to determine and may involve the use of tests during surgery to determine the compression effect of the sling on the body tissues (such as in urethra in case of the UI treatment) that are supported by the sling. Some manual tests may be performed, or a more sophisticated urodynamic test like cystourethrography, may determine tension. It may be important for a surgeon to test or determine tension during surgery because of the high rate of urine retention (inability to void) associated with this procedure and to avoid miscalculation of the required tension.
In an existing solution to determine the tension, the surgeon places a tubular member such as a hemostat between the sling and the body tissues such as urethra. The tubular member facilitates measurement of an extra amount of material between the sling and the body tissue that is supported by the sling. The extent of the slack between the sling and the body tissue is determined based on the size of the tubular member being used.
In accordance with the foregoing, there is a need for devices and methods for providing an improved bodily implant that ensures an appropriate amount of slack between the sling and the body tissues (that are being supported by the sling) so that the sling is neither left too loose nor tight within the body of the patient.